The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Avalon Fetal Monitor, Models Fm20 And Fm30.
| Device ID | K052795 |
| 510k Number | K052795 |
| Device Name: | PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 |
| Classification | System, Monitoring, Perinatal |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2005-12-30 |
| Summary: | summary |